A Study Investigating the Cardioprotective Benefits of Remote Ischaemic Postconditioning in Patients Presenting With Non ST Elevation Acute Coronary Syndromes Undergoing In-hospital Percutaneous Coronary Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Procedural Myocardial Infarction
- Sponsor
- University College, London
- Enrollment
- 626
- Primary Endpoint
- Peri-Procedural Myocardial Injury
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
Detailed Description
Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study. Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography. This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection. Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups. Primary end point Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention
Exclusion Criteria
- •Known renal failure
- •Known liver disease
- •Peripheral vascular disease involving upper limbs
- •Inability to consent
Outcomes
Primary Outcomes
Peri-Procedural Myocardial Injury
Time Frame: 24 hours post PCI
Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit